Infundibulum determines the folding and expression patterns of prosthetic heart valves

Abstract

The loading funnel for the prosthetic heart valve includes a proximal connector configured to releasably secure the funnel to a holding tube for the prosthetic heart valve, a distal end for receiving the prosthetic heart valve in at least a partially expanded state, and a passageway extending between the distal end and the proximal connector. The passageway includes a conical portion that is wider at the distal end and narrower at the proximal end and centered along a cone axis. One or more internal fins each extend from a relatively proximal position within the cone portion to a relatively distal position within the cone portion and project toward the cone axis.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 322,397, filed March 22, 2022, the disclosure of which is hereby incorporated by reference into this application. [Background technology]

[0002] In the United States, valvular heart disease, specifically aortic and mitral valve disease, is a significant health problem. Traditional valve replacement, or orthotopic replacement of a heart valve, is an "open-heart" surgical procedure. Briefly, the procedure requires surgical incision of the chest, initiation of extracorporeal circulation with cardiopulmonary bypass, stopping and opening the heart, removal and replacement of the diseased valve, and restarting the heart. Valve replacement typically carries a 1-4% risk of death in otherwise healthy individuals, with the mortality rate associated with this procedure being significantly higher, primarily due to the need for extracorporeal circulation. Furthermore, open-heart surgery is often poorly tolerated by elderly patients. Thus, the mortality rate and cost of valve replacement therapy would be significantly reduced if the extracorporeal component of the procedure could be eliminated.

[0003] Although transcatheter aortic valve replacement has been the subject of intense investigation, the mitral valve has received less attention, reflecting in part the high level of complexity associated with the native mitral valve and therefore the challenges associated with inserting and anchoring a replacement prosthesis.

[0004] Recent developments in the field have provided devices and methods for mitral valve replacement that are less invasive and less risky to the patient. Such devices typically include a prosthetic valve that is placed within the native annulus and held in place using anchors seated on the exterior surface of the heart near the apex, which anchors are preferably at least sized to provide sufficient security for placement in the heart.

[0005] Such valves are typically delivered using a long, thin device into which the valve can be pulled and from which it can emerge in the opposite direction. As the valve is pulled into the device, it also radially collapses to first fit within the device and then travels along the delivery lumen. The delivery lumen must be thin enough to extend through the patient's body and into the native annulus without undue trauma. Thus, the valve folds when loaded and typically unfolds in the reverse of the folding pattern when exiting the lumen.

[0006] Other recent developments in the field have provided prosthetic valves of asymmetric design that correspond to the asymmetric structure of the native mitral valve. Such valves have asymmetric frames with specific structures intended to land on the recognized divisions of the leaflets of the native mitral valve (A1, A2, A3, P1, P2, P3). Precision in placing the implanted valve in a desired rotational orientation (sometimes referred to as "clocking") relative to the native leaflets generally tends to improve the stability and therapeutic outcome of the implanted prosthetic valve.

[0007] The prosthetic valve may be loaded into the delivery device such that the fold pattern is unpredictable and the rotational orientation of the valve within the delivery device is unknown. Thus, the clinician can refer to the patient's images early and repeatedly during the delivery of the valve to observe how the valve unfolds and determine the rotational orientation of the prosthetic valve relative to the delivery device. Depending on the unfolding pattern and orientation discovered from the images, the clinician can carefully rotate or otherwise adjust the delivery device. If the clinician knew the fold pattern and orientation of the valve in advance, the valve delivery procedure could be more efficient. It should be understood that the terms "fold" and "unfold" as used herein generally refer to the collapsing and expanding of the prosthetic heart valve, respectively, or to the loading and deploying of the prosthetic heart valve into and from the delivery device, respectively. Summary of the Invention

[0008] According to some aspects of the present disclosure, a loading funnel for a prosthetic heart valve can include one or more fins extending through the funnel toward a central axis of a conical portion of a passageway. Each of the fins can extend from a respective relatively proximal position in the passageway to a respective relatively distal position in the passageway. Each of the fins can extend along a respective fin axis that intersects the central axis. Each of the relatively proximal and relatively distal positions can be within the conical portion of the passageway. The funnel can include just one fin or multiple fins. The multiple fins can be evenly distributed angularly about the central axis. In another example, the multiple fins can be two fins extending along different respective fin axes, each of which has a radial component with respect to the central axis, and the angle between the two radial components can be less than 180°. The radial components can be at right angles to each other. Alternatively or additionally, the angle between the radial components may correspond to the angle between the hips of a prosthetic valve intended to be loaded through the funnel, the hips being defined at two angular positions on the cuff of the valve where the portion of the cuff intended to reach the anterior leaflet of the native heart valve meets the portion of the cuff intended to reach the posterior leaflet of the native heart valve. The funnel may have a visible angle indicator on its outer surface so that the placement of the one or more fins can be determined by observing the outer surface of the funnel.

[0009] During the loading process, the prosthetic valve may be angularly oriented in the funnel such that the one or more fins bias each portion of the valve inward so that the valve unfolds in a desired pattern when delivered. In some examples where the one or more fins is just one fin or just three evenly distributed fins, the valve may be placed in the funnel such that the center of the portion of the collar intended to reach the posterior leaflet of the native heart valve is aligned with the fin. In some examples where the funnel includes at least two fins, the valve may be angularly oriented in the funnel such that each hip is aligned with two fins. The valve may be placed in the funnel such that either or both of the portion of the cuff intended to reach the anterior leaflet of the native heart valve and the portion of the cuff intended to reach the posterior leaflet of the native heart valve contact the conical portion of the funnel only in an area where there are no fins. The area may be defined between the two fins. In some configurations included in any of the aforementioned examples, the valve may be placed in the funnel such that the hips are symmetrically located on either side of the plane where the one or more fins are symmetrically distributed. [Brief description of the drawings]

[0010] [Figure 1] FIG. 1 is an exploded view of an exemplary prosthetic heart valve. [Diagram 2] FIG. 2 is a side view of the inner and outer frame assembly of the valve of FIG. 1 in an expanded configuration. [Diagram 3] FIG. 2 is a front view of the inner and outer frame assembly of the valve of FIG. 1 in an expanded configuration. [Figure 4] 2 is a top view of the inner and outer frame assembly of the valve of FIG. 1 in an expanded configuration. [Diagram 5] FIG. 1 is a schematic diagram of a valve loading device according to one embodiment. [Figure 6A] FIG. 6 is a side view of the outer funnel of the valve loading device of FIG. 5. [Figure 6B] FIG. 6B is a cross-sectional view of the outer funnel of FIG. 6A. [Figure 6C]FIG. 6B is a perspective view of the inside of the passage of the outer funnel of FIG. 6A. [Figure 7A] FIG. 6B is a distal end view of the conical portion of the outer funnel of FIG. 6A. [Figure 7B] 7B is a distal end view of the valve of FIG. 1 being partially compressed by pulling proximally through the cone portion of FIG. 7A. FIG. [Figure 7C-1-7C-2] 7B shows a side view and an end view, respectively, of the first stage of deployment of the valve of FIG. 1 after loading according to FIG. 7B. [Fig. 7D-1-7D-2] 7C-1 and 7C-2 show side and end views, respectively, of a deployment step subsequent to the step shown in FIG. 7C-1 and FIG. [Figure 7E-1-7E-2] 7D-1 and 7D-2 show side and end views, respectively, of a deployment step subsequent to the step shown in FIG. 7D-1 and FIG. 7D-2. [Fig. 7F-1-7F-2] 7E-1 and 7E-2 show side and end views, respectively, of a deployment step subsequent to the step shown in FIG. 7E-1 and FIG. 7E-2. [Figure 8A] FIG. 6B is a distal end view of another example of a cone that can be incorporated into the outer funnel of FIG. 6A. [Figure 8B] 8B is a distal end view of the valve of FIG. 1 being partially compressed by pulling proximally through the cone of FIG. 8A. [Figure 9A] FIG. 6B is a distal end view of another example of a cone that can be incorporated into the outer funnel of FIG. 6A. [Figure 9B] 9B is a distal end view of the valve of FIG. 1 being partially compressed by pulling proximally through the cone of FIG. 9A. [Figure 10A] FIG. 6B is a distal end view of another example of a cone that can be incorporated into the outer funnel of FIG. 6A. [Figure 10B] FIG. 10B is a distal end view of the valve of FIG. 1 being partially compressed by pulling proximally through the cone of FIG. 10A. [Figure 10C] 10B is a distal end view of the valve of FIG. 1 being partially compressed by pulling proximally through the cone of FIG. 10A, the valve being in a different angular orientation within the cone than shown in FIG. 10B. [Figure 11A-1-11A-2]10D and 10E show side and end views, respectively, of the first stage of deployment of the valve of FIG. 1 after loading according to FIG. 10C. [Fig. 11B-1-11B-2] 11A-1 and 11A-2 show side and end views, respectively, of a deployment step subsequent to the step shown in FIG. [Fig. 11C-1-11C-2] 11B-1 and 11B-2 show side and end views, respectively, of a deployment step subsequent to the step shown in FIG. [Fig. 11D-1-11D-2] 11C-1 and 11C-2 show side and end views, respectively, of a deployment step subsequent to the step shown in FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] As used herein, the term "proximal" when used in connection with a delivery device or a component of a delivery device refers to the end of the device that is closer to the user when the device is being used as intended, whereas the term "distal" when used in connection with a delivery device or a component of a delivery device refers to the end of the device that is farther from the user when the device is being used as intended. As used herein, the terms "substantially," "generally," "approximately," and "about" are intended to mean that small deviations from absolute values ​​are included within the scope of the term so modified.

[0012] An exemplary prosthetic heart valve 110 that can be used in various embodiments of the present disclosure is shown in an exploded view in Figure 1. The valve 110 includes an inner structure or assembly 112 and an outer structure or assembly 114. The valve 110 can be connected to a tether 160 and a tether anchor 154, which may or may not be compressible.

[0013] The inner assembly 112 includes an inner frame 140, an outer wrap 152, which may be tubular, and a leaflet structure 136 (including articulating leaflets 138, which define the valve function). The leaflet structure 136 may be sutured to the inner frame 140, or a portion of the inner frame 140 may be used for that purpose. The inner assembly 112 is positioned and secured within the outer assembly 114, as described in more detail below.

[0014] The outer assembly 114 includes an outer frame 170. The outer frame 170 may, in various embodiments, have an outer frame covering of tissue or fabric (not shown) or can be without an outer covering to provide an exposed wire frame to promote tissue ingrowth. The outer frame 170 may also have an articulating collar or cuff (not shown) covered by a tissue or fabric covering 148.

[0015] The tether 160 is connected to the valve 110 by the inner frame 140. Thus, the inner frame 140 includes a tether connecting or clamping portion 144 that connects the inner frame 140, and thus the expanded valve 110, to the tether 160.

[0016] The outer frame 170 and the inner frame 140 are shown connected to each other in Figures 2-4, which are front, side, and top views, respectively. Together, the two frames form a structural support for the leaflet structure of the valve, such as the leaflet structure 136 of Figure 1. Specifically, the inner frame 140 supports the leaflet structure 136, the outer frame 170 anchors the prosthetic valve 110 to the native annulus, and the inner frame 140 maintains a generally cylindrical configuration even when forces applied to the outer frame 170 deform the outer frame 170. As will be explained more fully below, the frames support the leaflet structure 136 in a desired relationship to the native annulus, support coverings for the two frames to provide a barrier against blood leakage between the atrium and ventricle, and connect (by the inner frame 140) to a tether 160 to help hold the prosthetic valve in place in the native annulus by connecting the free end of the tether and the tether anchor 154 to the ventricular wall. The two frames may be joined at multiple connection points (representative points are identified as "C"), for example, six connection points. In this embodiment, the connection of the frames is implemented by passing mechanical fasteners, such as short lengths of suture or wire, through openings in the connection portion 171 of the outer frame 170 and corresponding openings in the longitudinal posts 142 in the body portion of the inner frame 140. Thus, the inner frame 140 is positioned within the outer frame 170 and securely connected thereto.

[0017] As shown in Figures 2-4, the assembly formed by the combination of the outer frame 170 and the inner frame 140 includes a neck portion 184 that serves as a scaffold for the neck of the assembled valve 110. The neck of the valve 110 extends through the native mitral annulus after the valve 110 is implanted, allowing blood to flow from the left atrium to the left ventricle while preventing or at least inhibiting blood from flowing from the left ventricle to the left atrium. The neck portion 184 is generally contained within the area enclosed by the dashed border 180 in Figure 4, and the portion of the outer frame 170 extending radially outward of the dashed border 180 defines a collar that surrounds the neck portion 184.

[0018] The collar defined by the outer region of the outer frame 170 provides a scaffold for the portions of the valve 110 that are intended to reach the leaflets of the native mitral valve. The collar can therefore be considered to include regions A1, A2, A3, P1, P2, P3 that correspond to similarly identified regions of the native leaflets. That is, the typical anatomy of the anterior leaflet of the native human mitral valve includes regions or segments commonly referred to as A1, A2, and A3, and the typical anatomy of the posterior leaflet of the native human mitral valve includes regions or segments commonly referred to as P1, P2, and P3, and the collar provides a scaffold for the portions of the valve 110 that are intended to reach those regions when the valve 110 is implanted. Those regions appear frequently in the literature on the anatomy of the human heart and are known to those skilled in the art of designing or implanting mitral valve prostheses. As shown in FIG. 4 , the A1, A2, A3, P1, P2, P3 regions of the outer frame 170 each provide a scaffold for a respective region of the valve 110 that is intended to reach a similarly named portion of one of the native leaflets. The portion of the valve 110 that reaches the native leaflet fixes the valve 110 to the atrial side of the mitral valve and prevents the valve 110 from sliding into the left ventricle. The safety of the seating of the valve 110 on the atrial side of the native mitral valve is generally improved in cooperation with the accuracy of the alignment of the A1, A2, A3, P1, P2, P3 regions of the outer frame 170 to the corresponding regions of the native mitral valve. In other words, a prosthetic mitral valve whose native mitral annulus and leaflets have a complex and irregular shape, and which is specifically shaped and designed to have properties that complement the complex and irregular shape, can be expected to provide better anchorage and function compared to a rotationally symmetric prosthetic heart valve that is not specifically designed to follow the complex contours of the native mitral valve.

[0019] The collar (sometimes referred to as the atrial flare) provided by the portion of the outer frame 170 outside the dashed border 180 is asymmetrical to mimic the asymmetry of a typical human mitral valve. Because the anterior leaflet of the human mitral valve is larger than the posterior leaflet of the human mitral valve, the anterior regions A1, A2, A3 of the outer frame 170 extend radially farther from the center of the neck portion 184 than the posterior regions P1, P2, P3 of the frame 170. Thus, the anterior portion of the collar provided by the frame 170, including A1, A2, and A3, is larger and extends radially farther from the center of the neck portion 184 and the entire neck of the valve 110 than the posterior portion of the collar, including P1, P2, and P3.

[0020] The hip 186 is defined by two portions of the collar where the anterior portion A1, A2, A3 of the collar meets the posterior portion P1, P2, P3 of the collar. The hip 186 tends to align with the commissures of the native mitral valve when the prosthetic heart valve 110 is implanted. Although the term "hip" is used herein, the hip may also be considered as the lateral or commissure portions of the collar of the outer frame 170. It should be further understood that although the A1-A3 and P1-P3 segments of the collar of the outer frame 170 are shown by dashed lines in FIG. 4, there may be some variation from the exact depiction shown, as it should be understood that the collar of the outer frame 170 is a continuous structure and that not every mitral valve of a patient is identical to every other patient's mitral valve. In other words, the relative placement of the A1-A3 and P1-P3 segments is static, but the A1-A3 and P1-P3 segments may be slightly larger or smaller than the particular depiction shown in Figure 4. As a result, the hip 186 that separates the A1-A3 and P1-P3 segments of the collar may be positioned slightly differently than shown in Figure 4, although it should still be understood that Figure 4 accurately represents where each of the A1-A3 and P1-P3 and hip segments may typically be positioned. For example, in some embodiments, the hip 186 may be more closely aligned with the major axis of the ellipse of the dashed boundary 180.

[0021] Valve 110 is merely one example of a prosthetic valve that may be utilized with the concepts of the present disclosure. Thus, elsewhere in this disclosure, reference is made to valve 110 for purposes of describing other devices and concepts that may interact in a similar manner with different prosthetic valves. Indeed, the concepts disclosed herein may be most useful in connection with the placement of rotationally asymmetric expandable prosthetic heart valves, but may also be useful in connection with the placement of rotationally symmetric expandable prosthetic heart valves.

[0022] 5 is a schematic diagram of a valve loading device 260. The valve loading device 260 includes a funnel assembly 215, a loading handle assembly 265, and a valve retaining tube 125. Prior to connecting the valve retaining tube 225 to a handle assembly and catheter assembly for the prosthetic valve 110, the valve is loaded into the valve retaining tube 225 using the valve loading device 260. The valve 110 is first placed into the funnel assembly 215 to move the valve from an expanded configuration to a compressed configuration. It should be understood that without an applied force, the valve 110 will tend to return to the expanded configuration and thus require some type of manipulation to transition the valve 110 to the compressed configuration for delivery. The funnel assembly 215 includes an outer funnel 264 and an inner funnel or centering cone 262. The valve 110 is placed into the outer funnel 264, and then the inner funnel 262 is connected to the outer funnel 264 to sandwich the valve therebetween and compress the valve into the desired shape and configuration in a controlled manner. The valve retention tube 225 can be releasably connected to the funnel assembly 215 and the loading handle assembly 265, for example, via a quick connect coupler or any other type of releasable connection mechanism. Although an inner funnel 262 and an outer funnel 264 are shown and described in connection with FIG. 5, it should be understood that in other embodiments, only a single funnel may be used without the need to sandwich the valve between two funnels.

[0023] The loading handle assembly 265 includes a handle 257 (also referred to as a "main loading knob" or "actuator"), a retention mechanism 268 for securing the tether 160, and a loading lead screw 266 operably connected to the handle 257. With the valve retention tube 225 connected to the funnel assembly 215 and the loading handle assembly 265, and the tether 160 extending from the valve 110 secured to the retention mechanism 268, the valve loading device 260 can be actuated to move the valve 110 from a first configuration in which the valve 110 is disposed within the funnel assembly 215 to a second configuration in which the valve 110 is disposed within the valve retention tube 225. More specifically, the handle 257 can be actuated or rotated, thereby moving the lead screw 266 relative to the handle 257, thereby moving the valve retention tube 225 and the funnel assembly 215 away from the handle 257. In operation, with the valve 110 in a fixed position (i.e., stationary) relative to the handle 257 (by securing the tether to the retention mechanism 268), the funnel assembly 215 is moved away from the handle and the valve retention tube 225 is moved over the valve to position the valve within the interior region of the valve retention tube 225. However, it should be understood that other mechanisms may be suitable for moving the prosthetic valve 110 through the funnel assembly 215 and into the valve retention tube 225. For example, an actuator may be used to pull the retention mechanism 268 proximally to pull the valve 110 proximally through the funnel assembly 215 and into the valve retention tube 225. In other embodiments, the user may simply grasp the tether 160 (instead of being held by the retention mechanism 268) and pull proximally to pull the valve 110 through the funnel assembly 215 and into the valve retention tube 225.

[0024] After the valve 110 is loaded into the valve retention tube 225, the valve retention tube 225 can be disconnected from the valve loading device 260 and then connected to a valve delivery device, or the valve loading device 260 can be reconfigured to act as a valve delivery device. In either case, a catheter is connected to the valve loading tube 225 and the valve 110 can be delivered to the native mitral valve by the catheter.

[0025] Further details regarding the various components and operation of the valve loading device 260 and devices for delivering prosthetic valves can be found in U.S. Patent No. 10,667,905, filed October 11, 2017, which is incorporated herein by reference in its entirety. Further details regarding the valve 110 and other examples of devices for loading and delivering prosthetic valves can be found in U.S. Patent Application Publication No. 2021 / 0186695, filed December 16, 2020, which is incorporated herein by reference in its entirety.

[0026] The outer funnel 264 of the valve loading device 260 described above is shown in Figures 6A-6C. The outer funnel 264 extends between a distal end 270 and a proximal end 272. The distal end 270 may include external threads 274 that serve as an attachment point for the inner funnel 262 so that the inner funnel 262 can seal and close the distal end 270, although, as noted above, in other embodiments, a single funnel may serve the functions of the assembled inner funnel 262 and outer funnel 264. The proximal end 272 may include a lip 276 to facilitate releasable connection of the outer funnel 264 to the valve retention tube 225. The external threads 274 and lip 276 are merely examples of engagement features that may be provided on either end 270, 272 of the outer funnel 264 to releasably connect the inner funnel 262 and the valve retention tube 225 to the outer funnel 264. Thus, either or both of the external threads 274 and lip 276 may be replaced with a different type of engagement feature, such as an internal thread, a quick connect mechanism, or any other releasable engagement mechanism.

[0027] The exterior surface of the outer funnel 264 may include a visible angle indicator 280, which in the illustrated example may be a flat portion of the otherwise rounded exterior surface, but in other embodiments may be other examples of notches, protrusions, ribs, contrasting color markings, or any other visible indicia. The visible angle indicator 280 is preferably distinct from the appearance of the exterior surface of the outer funnel 264 at other circumferential locations, meaning that an observer can determine the angular orientation of an interior feature of the outer funnel 264, such as the fins 288, from the placement of the visible angle indicator 280. Two visible angle indicators 280 are shown in the illustrated example, one located on the lip 276 and the other just proximal to the male threads 274, but in other examples the visible angle indicators 280 may be provided in any number and at any location along the exterior surface of the outer funnel 264.

[0028] A passageway 282 extends within the outer funnel 264 from the proximal end 272 to the distal end 270. The passageway 282 includes a cavity 284 at the distal end 270 that provides a distal opening of the outer funnel 264, the cavity 284 being large enough in diameter to receive the valve 110 in at least a partially expanded state. Proximal to the cavity 284 is a tapered or conical portion 286 of the passageway 282, which may be defined within the tapered portion or cone 278 of the outer funnel 264. The central longitudinal axis 279 of the passageway 282 and the entire outer funnel 264 is also the central or cone axis of the conical portion 286, i.e., the axis 279 extends through the center point of a theoretical circular base at the distal end of the conical portion 286, through the theoretical proximal point where the conical portion 286 would converge if the conical portion 286 were not truncated. Similarly, although cavity 284 is cylindrical in the illustrated example, cavity 284 may be of any other shape that allows valve 110 to be received therethrough, including, for example, a polygonal rather than circular cross-section, a shape that varies in size along axis 279, or other non-cylindrical shapes.

[0029] For purposes of this disclosure, references to cone 278 and cone portion 286 include, by way of example, a perfect cone or a truncated cone shape, but are not limited to a perfect cone. For example, the interior of cone portion 286 may be a truncated trapezoid of any other three-dimensional shape in which the cross-sectional shape perpendicular to axis 279 is completely or substantially constant, tapering more at the distal end and more narrowly at the proximal end. The exterior shape of cone 278 may be any shape, including any of the possible cone portion 286 shapes discussed above.

[0030] The passageway 282 may include ribs or fins 288 that extend inwardly from an outer surface of the passageway 282 toward the central axis 279. With particular reference to FIG. 6C , in the illustrated example, each fin 288 extends within the conical portion 286 of the passageway 282 between a respective relatively proximal point 290 and a respective relatively distal point 291. A fin axis 293 is defined for each fin 288 as a line that includes the relatively proximal point 290 and the relatively distal point 291 of the corresponding fin 288. Thus, each illustrated fin 288 extends along a respective fin axis 293 that includes the respective relatively proximal point 290 and the respective relatively distal point 291. Because the fin axes 293 are straight, but the tapered or conical sections 278 may have curved internal profiles, the phrase "extend along" in this example includes both fins that may conform exactly to the trajectory of their respective fin axes, and fins 288 that deviate from their respective fin axes 293 radially relative to the central axis 279, as shown in the illustrated example. Each fin axis 293 in the illustrated example intersects the central axis 279. In other examples, some or all of the fins may not extend along any identifiable axis, some or all of the fins may deviate tangentially to their respective axes, some or all of the fin axes may not intersect the central axis 279, or any combination of the foregoing.

[0031] In the illustrated example, relatively proximal point 290 and relatively distal point 291 are each located within conical portion 286, i.e., fin 288 is confined to conical portion 286. However, in other examples, relatively proximal point 290, alone or together with relatively distal point 291, may be located proximal to conical portion 286. In further examples, relatively distal point 291, alone or together with relatively proximal point 290, may be located within cavity 284 or at least distal to conical portion 286. Thus, in various examples, fin 288 can extend either or both proximally and distally to conical portion 286, or may be located entirely proximally or entirely distally to conical portion 286. For the outer cone 264 of the illustrated example, the presence of fins 288 only on the cone portion 286 is effective for controlling the folding pattern of the valve 110 as it is pulled proximally through the outer funnel 264, although the location of fins 288 in any of the other positions previously described may be effective for controlling the folding pattern of the valve 110 for outer funnels 264 of other proportions.

[0032] In Figure 7A, the cone 278 is shown alone from a distal perspective, facing proximally along a central axis 279, which is not visible in Figure 7A. Thus, the radial components of the fin axis 293 relative to the central axis 279 are shown in Figure 7A. As can be seen, exactly two fins 288 are defined within the cone 278, with the radial components of the fin axis 293 extending in either direction from the central axis 279. Thus, the fin angle 294 defined between the radial components of the fin axis 293 is 180°, and the fins 288 are symmetrically disposed on either side of the plane of symmetry 295. Two areas without fins 288 are defined on either side between the fins 288.

[0033] 7B, valve 110 has a fold pattern influenced by fins 293 when it is placed on cone 278 (not visible in FIG. 7B) and pulled proximally. Valve 110 is placed such that neck portion 184 and tether 160 (neither neck portion 184 nor tether 160 are visible in FIG. 7B) extend proximally into cone 278, with at least tether 160 extending through a narrow proximal opening in cone 278. Thus, the collar of valve 110 seats on the wider distally facing portion of cone 278 and narrows, compresses or folds over as tension on tether 160 pulls valve 110 proximally.

[0034] Additionally, the valve 110 is also mounted substantially symmetrically with respect to the plane of symmetry 295. Thus, both the hips 186 and the fins 288 are symmetrically distributed on either side of the plane of symmetry 295. The hips 186 of the valve 110 and the front portion of the collar, including areas A1, A2, A3 (only A2 is labeled in FIG. 7B for clarity), all contact only the cone 278 in one of the finless areas defined between the fins 288 on one side. However, the rear portion of the collar of the valve 110, including areas P1, P2, P3 (only P2 is labeled in FIG. 7B for clarity), contacts both fins 288. Specifically, in this example, the hips 186, and also (but not necessarily) the P1 and P3 segments, contact the fins 288 when pulled through the cone 278. Thus, the pinch point 296 where the valve 110 first buckles as it is pulled against the fin 288 can be seen symmetrically and behind or at the hip 186 .

[0035] In addition to being the location where the valve 110 first folds during loading into the delivery catheter (or into a valve holder connected to the delivery catheter), the pinch point 296 is also the location where the valve 110 last unfolds during deployment from the delivery catheter. Furthermore, once the pinch point 296 is established, the valve 110 will tend to fold consistently and predictably throughout loading and therefore unfold conversely consistently and predictably when deployed. Thus, the fins 288 allow for a priori knowledge of the deployment or "expression pattern" for each or at least most deliveries or deployments of a given type of valve 110 loaded through the cone 278. The rotational positioning of the loaded valve 110 within the valve retention tube 225 can also be priori known by paying attention to the angular orientation of the valve 110 relative to the fins 288. Observation of the visible angle indicator 280 can aid in determining the angular placement of the valve 110 and fins 288 during loading.

[0036] Knowing the angular placement and expression pattern of the valve 110 in advance can reduce the need for patient image references and delivery device adjustments during surgery to deliver or place and implant the valve 110, thus making the surgery faster, simpler, and more efficient. The folding pattern produced by the cone 278 of FIG. 7A is merely one example, and cones adapted to produce other folding patterns can be used to accommodate different patient anatomies, different valve types and sizes, and differences in clinician preferences, among other things. Other examples of producing various pinch points, folding patterns, and expression patterns are described below.

[0037] 7C-7F show successive stages of deployment of the valve 110 from a tube in which the valve 110 is loaded through the cone 278 in the orientation shown in FIG. 7B. The stages are shown in side views in each figure labeled "-1" and end views in each figure labeled "-2." That is, the first stage shown is shown in side view in FIG. 7C-1 and end view in FIG. 7C-2, the next stage is shown in side view in FIG. 7D-1 and end view in FIG. 7D-2, and so on. As can be seen, during deployment, the A2 region of the valve 110 emerges first and generally extends the furthest in each stage, followed by the P2 region. Due to the two pinch points 296, the hip 186 has limited radial emergence until the final stage shown in FIG. 7F, where the sides of the valve 110 are the last portions of the valve 110 to radially expand during deployment. Although Figures 7C-7F are described herein with respect to placement of valve 110, reviewing Figures 7C-7F in reverse order can illustrate the bending stages that valve 110 undergoes as it is loaded through cone 278.

[0038] FIG. 8A shows another example cone 378. The cone 378 can be used in place of the cone 278 in the outer funnel 264 or another otherwise similar funnel. The interior of the cone 378 thus provides a conical portion 386 of the passageway with ribs or fins 388 extending inwardly toward the central axis of the cone portion 386, each fin 388 also extending along a respective fin axis 393. As with FIGS. 7A and 7B, FIG. 8A is from a distal perspective looking proximally along the central axis of the cone 378. Thus, the radial components of the fin axes 393 are shown in FIG. 8A. The fin angles 394 between the radial components of the fin axes 393 are equal between each pair of adjacent fin axes 393. Because the cone 378 includes exactly three fins 393, each fin angle 394 is 120°. Three finless regions are defined within conical portion 386 , with each such region being defined between a pair of adjacent fins 388 .

[0039] The fins 388 are distributed symmetrically with respect to a plane of symmetry 395, with one fin 388 extending rearward on the plane of symmetry 395. Thus, when the valve 110 is placed on the cone 378, such that the hips 186 are also symmetrically located on either side of the plane of symmetry 395 in a manner similar to that described above with respect to Figure 7B, the centre of the P2 region of the collar of the valve 110, and therefore the entire rear portion, is aligned with the fin 388 extending along the plane of symmetry 395. Thus, as shown in Figure 8B, there is a pinch point 396 in the angular centre of the rear portion of the collar of the valve 110.

[0040] Because the hips 186 of the illustrated example of the valve 110 are 120° apart from one another on the anterior side, each hip 186 contacts one of the fins 388, so that two pinch points 396 are aligned with the hips 186 and one pinch point 196 is posterior to the hips 186. Thus, the anterior portion of the collar of the valve 110 contacts the cone 378 only in the finless area defined between two of the fins 388. However, in other examples where the angles between the hips 186 or fins 388 are different, the hips 186 may contact the fins 388 or may contact the cone 378 in different or common finless areas, and the proximal or anterior portion of the collar of the valve 110 contacts both fins 388. For example, if the hips 186 were positioned generally along the major axis of the ellipse illustrated by the dashed boundary 180 in FIG. 4, then the hips 186 would both be positioned rearward of the two forward fins 388.

[0041] 9A shows another example cone 478. Similar to cone 378, cone 478 can be used in place of cone 278 in outer funnel 264 or another otherwise similar funnel. The interior of cone 478 thus provides a conical portion 486 of the passageway. Cone 478 includes exactly one rib or fin 488 that extends inwardly toward the central axis of conical portion 486. Thus, a single finless area extends across the entirety of conical portion 486, except for fin 488 itself.

[0042] 7A-8B, is from a distal perspective looking proximally along the central axis of cone 478. Thus, FIG. 9A shows the radial component of fin axis 493. As can be seen, fin axis 493 is encompassed by plane of symmetry 495, and the radial component of fin axis 493 extends rearward.

[0043] As discussed above with respect to FIGURE 7B, when the valve 110 is placed symmetrically on the cone 478 with respect to the plane of symmetry 495, the P2 region and the rear portion of the collar of the valve 110 are generally centered and aligned with the fin 488. Thus, as the valve 110 is pulled proximally through the cone 478, a single pinch point 496 is created in the center of the P2 region, and the remainder of the valve 110, including both the hip 186 and the entire anterior portion of the collar of the valve 110, contacts the cone 478 only in the fin-free area. The single pinch point 496 can be observed in FIGURE 9B.

[0044] FIG. 10A illustrates another example cone 578. Like cones 278, 378, 478, cone 578 can be used in place of cone 278 in outer funnel 264 or another otherwise similar funnel. The interior of cone 578 thus provides a conical portion 586 of the passageway with ribs or fins 588 extending inwardly toward a central axis of cone portion 586, each fin 588 also extending along a respective fin axis 593. As with FIGS. 7A-9B, FIG. 10A is from a distal perspective, looking proximally along the central axis of cone 578. Thus, the radial component of fin axis 593 is shown in FIG. 10A. Because the cone 578 includes exactly two fins 588 and the radial components of the fin axes 593 are not in opposite directions, a narrow fin angle 594 is defined on one side between the radial components of the fin axes 593 and a wide fin angle 597 is defined on the other side between the radial components of the fin axes 593. Similarly, a narrow finless area is defined between the fin axes 593 on one side and a wide finless area is defined between the fin axes 593 on the other side.

[0045] In the illustrated configuration, when the valve 110 is placed generally symmetrically in the cone 578 with respect to the plane of symmetry 595 as described above with respect to FIG. 7A, and in particular when a forward portion of the collar of the valve 110 is placed against the narrow finless section of the cone portion 586 and a rearward portion of the collar of the valve 110 is placed against the wider finless section of the cone portion 586, the narrow fin angle 594 may be less than the acute angle between the hips 186, such that the hips 186 may be angularly aligned slightly rearward of the fins 588. Specifically, in the configuration shown in FIGS. 10A-10C, the acute angle between the hips 186 is at or about 120° and the narrow fin angle 594 is 90°. Thus, as the valve 110 is pulled proximally through the cone 578, a pinch point 596 is created just forward of each hip 186. In other configurations, the fin angles 594, 597 may be approximately equal to the angle between the hips 186 so that when the valve 110 is placed symmetrically in the cone 578 with respect to the plane of symmetry 595, the hips 186 may contact and be angularly aligned with the fins 588.

[0046] Figure 10C shows the valve 110 partially folded when pulled proximally through the cone 578, which is inverted relative to the valve 110 as compared to the configuration shown in Figure 10B. Thus, while in Figure 10B the fins 588 were symmetrically aligned in front of the hip 186, in Figure 10C the fins 588 both contact the P2 region of the valve 110. Thus, two pinch points 596' are created in the P2 region.

[0047] 10A-10C, narrow fin angle 594 is 90°, wide fin angle 597 is 270°, and the angles between the hips 186 are equal. However, these angles are merely an example. The angle between the hips 186 is limited by human anatomy, but may vary slightly according to different valve designs, and the angle between the fins 588 may vary accordingly. On the other hand, a cone may have just two fins with angles other than 90°, 180°, or 270° between each other, which may or may not match the angle between the hips of the valve with which it is used.

[0048] 11A-11D show successive stages of deployment of the valve 110 from the tube in which it is loaded, through the cone 578 with the hip 186 on the opposite side of the fin 588 as shown in FIG. 10C. The stages are shown in the side view of FIG. 11A-1 and the end view of FIG. 11A-2, respectively. That is, the first stage shown is shown in the side view of FIG. 11A-1 and the end view of FIG. 11A-2, the next stage shown is shown in the side view of FIG. 11B-1 and the end view of FIG. 11B-2, and so on. As shown, during deployment, the A2 region of the valve 110 emerges first and generally extends the furthest in each stage. Radial deployment of P2 and the entire posterior portion of valve 110 is delayed by the presence of posterior pinch point 596', which causes the posterior portion of valve 110 to remain folded inwardly during the intermediate stage shown in Figures 8D and 8E. Although none of the fins contact the anterior portion of valve 110 when loaded as shown in Figure 10C, loading valve 110 in the orientation shown in Figure 10C creates an inward fold at hip 186 as shown in Figures 11A-11D. Thus, as is particularly evident in Figures 11B and 11C, regions A1 and A3 radially expand later than region A2, although in the illustrated example, the posterior portion of valve 110 expands last. Although Figures 11A-11D are described herein with respect to placement of valve 110, reviewing Figures 11A-11D in reverse order can illustrate the bending stages that valve 110 undergoes when loaded through cone 578 oriented as shown in Figure 10C.

[0049] Each of the aforementioned cones 278, 378, 478, 578 includes different configurations of fins that can be used to create different fold patterns, such as those shown and described above. For each of the aforementioned cones, different fold patterns can also be created by angularly aligning the cone with respect to the valve differently than the specific examples given above. For example, any of the cones described above can be reversed such that both the ribs and the hips 186 remain symmetrical on either side of a common plane of symmetry. However, the valve 110 can also be placed on any of the cones described above such that the fins of the cone are not symmetrical with respect to the plane in which the hips 186 are symmetrical. Furthermore, the cones illustrated and described above are merely examples of how the fins can be arranged. Cones with other configurations can have any number of fins, evenly or unevenly distributed angularly around the cone.

[0050] It should be understood that, although a variety of different predictable folding patterns can be achieved using any of the combinations of ribs or fins described above, some folding patterns are particularly desirable in certain circumstances. In other words, the predictability and repeatability of deployment or placement is itself a major advantage of the present disclosure, and another advantage may be to use that predictability to have an ordered placement or presentation of the valve from the delivery device. For example, when utilizing a prosthetic mitral valve having a shape that generally corresponds to the shape of the native mitral valve, it may be most preferable to first place the A1, A2, and A3 segments of the outer stent from the delivery catheter without significant bending within the A1-A3 segments. Such a configuration may allow for particularly easy visualization of the valve orientation, which may allow for particularly good rotational alignment of the prosthetic valve with respect to the native mitral annulus. Additionally, the A1-A3 segments are typically the largest areas of the collar of the outer cuff, and when they are deployed first from the delivery catheter, a relatively large radial force can be applied by the A1-A3 segments to the native annulus to establish good placement of the prosthetic valve early in the deployment phase, for example by positioning the A1-A3 segments at the atrial base. It may be desirable for the hip 186 to "pop out" during deployment toward the native commissure of the mitral valve. For example, with reference to the folding patterns shown in Figures 7B and 10C, it can be predictable that the A1-A3 segments will be the first to deploy or deploy from the delivery catheter, and the hips remain pinched or folded while the A1-A3 segments begin to deploy. As deployment continues and the hip 186 begins to exit the delivery catheter, the hip 186 will deploy or expand or "pop out" toward the native commissure. While cones 278 and 578 may be most suitable for achieving the goals listed above, it should be understood that any of the cones described above may be utilized to achieve a particularly desirable (and predictable / reproducible) deployment or placement or expression pattern of the prosthetic heart valve.

[0051] Although not shown in the figures, the prosthetic mitral valve may include additional locking features, such as protrusions, barbs, spokes, etc., extending radially outward from the outer stent, so that they engage with the native tissue during deployment of the prosthetic mitral valve to help further secure the prosthetic heart valve within the native tissue. Such protrusions or similar structures may be strategically positioned with the intent of only engaging specific areas of the native mitral valve, or in other embodiments, they may be generally uniformly positioned around the outer stent circumference to maximize the likelihood that the protrusions will engage tissue to enhance anchorage. When such protrusions or other anchoring structures are provided, a predictable deployment pattern may be achieved, allowing a user, such as surgical personnel, to determine where the protrusions will initially engage tissue. In some instances, it may be desirable for the protrusions to initially engage the anterior A2 (or near A2) segment of the native mitral valve, which section may be considered a straight region of a "D" shape, since the mitral annulus is often described as having a "D" shape. Thus, if it is desired that the protrusions or barbs or outer stent first engage the A2 segment of the native anterior leaflet, a folding pattern can be selected in which the A2 segment of the collar of the outer stent is deployed and deployed first to contact the corresponding A2 segment of the native anterior leaflet. It should be understood that this particular use of the protrusions of the mitral stent to achieve an ordered and / or targeted engagement of the native valve tissue is merely exemplary, and that any of the cones and funnels described above, with or without the variants, can be used to create a particular desired, predictable and reproducible expression pattern to achieve the desired ordered and / or targeted engagement of the anchors with the native tissue.

[0052] In summary of the foregoing, a loading funnel for a prosthetic heart valve is disclosed. The funnel includes a distal end and an opposing proximal end. The distal end is for receiving the prosthetic heart valve in a partially expanded state or in some instances in a fully expanded state. The funnel also includes a passage extending between the distal end and a proximal connector. The passage includes a conical and / or tapered portion that is wider at the distal end of the conical and / or tapered portion than at the proximal end of the conical and / or tapered portion. The passage is centered along the cone axis. The passage also includes at least two internal fins. Each of the internal fins extends from a respective relatively proximal position within the passage to a respective relatively distal position within the passage. Each example includes a loading funnel having the aforementioned characteristics; and / or each fin may extend along a different respective fin axis that intersects the cone axis; and / or the radial components of the two fin axes relative to the cone axis may be 90° apart from each other; and / or the loading funnel may include only two fins in the cone portion; and / or the radial components of the two fin axes relative to the cone axis may be 180° apart from each other; and / or the funnel may include three internal fins in the cone portion. the internal fins may project toward the central axis and extend from a relatively proximal position to a relatively distal position along different respective fin axes that intersect the cone axis, and / or the radial components of the three fin axes relative to the cone axis may be 120° apart from each other, and / or the funnel may include a visible radial indicator on an outer surface of the funnel, and / or both the relatively proximal and relatively distal positions for each of the fins may be located within the conical portion of the passage.

[0053] A method of compressing a prosthetic heart valve for delivery to a patient is also disclosed. The method includes placing the prosthetic heart valve in a loading funnel. The prosthetic heart valve includes a frame defining a collar configured to contact an annulus of the native heart valve. The collar includes an anterior portion configured to contact an annulus of the annulus and a posterior portion configured to contact a posterior portion of the annulus, the anterior portion extending radially farther from the neck than the posterior portion. The method also includes translating the prosthetic heart valve through the loading funnel from a distal end of the loading funnel to a proximal end of the loading funnel to compress the prosthetic heart valve. The loading funnel includes a passage extending between a distal end and a proximal end of the loading funnel. The passage includes a tapered portion that is wider at the distal end than at the proximal end. The passage further includes at least two fins on an inner surface of the tapered portion of the passage. The at least two fins project toward a central longitudinal axis of the passage away from an inner surface of the tapered portion of the passage. During translation of the prosthetic heart valve through the loading funnel, each portion of the collar advances along at least two fins.Each example includes a method having the aforementioned characteristics; and / or the anterior and posterior portions together can provide an entire circumference of the collar; and / or during translation of the prosthetic heart valve through the loading funnel, the anterior portion of the collar can only contact a forward section of the tapered portion, the anterior section being devoid of internal fins; and / or the method can include pulling the valve proximally against the fins and into a retaining tube secured to a proximal end of the loading funnel, the fins can each extend from a respective relatively proximal position to a respective relatively distal position; and / or the valve can include a neck configured to permit fluid flow in a flow direction and inhibit fluid flow opposite the flow direction, the frame can define a collar around an end of the neck, the collar including an anterior portion and a posterior portion, the anterior portion extending radially farther from the neck than the posterior portion, the frame can further define two hips, each hip located at a respective point where the anterior portion meets the posterior portion, and the positioning step can include a step of positioning the prosthetic heart valve proximally against the fins and into a retaining tube secured to a proximal end of the loading funnel, the fins can each extend from a respective relatively proximal position to a respective relatively distal position; The valve may include symmetrically aligning the hips on either side of a plane along which the fins are symmetrically distributed; and / or the arranging step may include angularly aligning two of the fins and the hips about the cone axis; and / or the arranging step may include placing a front portion of the valve to contact the cone portion only at a front section of the cone portion and a rear portion of the valve to contact the cone portion only at a rear section of the cone portion, the front and rear sections being defined between the two fins and devoid of fins; and / or the arranging step may include angularly aligning the valve about the cone axis such that only the rear section contacts the fin; and / or the at least two fins may be exactly two fins, each of which extends along a respective fin axis, the cone axis and the fin axis being encompassed by a common plane; and / or the at least two fins may be exactly three fins.

[0054] A loading funnel for a prosthetic heart valve is also disclosed. The funnel includes a distal end and an opposing proximal end. The distal end is for receiving the prosthetic heart valve in a partially expanded state or in some examples in a fully expanded state. The funnel includes a passage extending between the distal end and a proximal connector. The passage includes a conical and / or tapered portion that is wider at the distal end of the conical and / or tapered portion than at the proximal end of the conical and / or tapered portion. The passage is centered along the cone axis. The passage also includes at least two internal fins. Each of the internal fins extends from a respective relatively proximal position within the passage to a respective relatively distal position within the passage. Each of the fins extends along a different respective fin axis that intersects the cone axis. The radial components of the two fin axes relative to the cone axis may be 90° apart from each other or 180° apart from each other. The funnel includes a visible radial indicator on an exterior surface of the funnel, and for each of the fins, both the relatively proximal and relatively distal positions are located within the conical portion of the passageway.

[0055] Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications can be made to the illustrative embodiments and that other arrangements can be devised without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. 1. A loading funnel for a prosthetic heart valve, said funnel comprising: A proximal end; a distal end for receiving the prosthetic heart valve in at least a partially expanded state; and a passageway extending between the distal end and the proximal connector; The passage comprises: a cone portion that is wider at a distal end and narrower at a proximal end and centered along a cone axis; at least two internal fins projecting toward the cone axis and each extending from a respective relatively proximal position within the passage to a respective relatively distal position within the passage; Loading funnel.

2. The loading funnel of claim 1 , wherein each fin extends along a different respective fin axis that intersects the cone axis.

3. 3. The loading funnel of claim 2, wherein the radial components of two fin axes relative to the cone axis are 90 degrees apart from each other.

4. 4. The loading funnel of claim 3, wherein said conical portion has only two fins.

5. 3. The loading funnel of claim 2, wherein the radial components of two fin axes relative to the cone axis are 180 degrees apart from each other.

6. 3. The loading funnel of claim 2, comprising three internal fins within said cone portion, said internal fins projecting toward said central axis and each extending from a relatively proximal position to a relatively distal position along a different respective fin axis that intersects said cone axis.

7. The funnel of claim 6 , wherein radial components of the three fin axes relative to the cone axis are 120° apart from each other.

8. The loading funnel of claim 1 , further comprising a visible radial indicator on an exterior surface of the funnel.

9. The loading funnel of claim 1 , wherein for each of the fins, the relatively proximal position and the relatively distal position are both located within the conical portion of the passageway.

10. a loading handle assembly configured to receive and apply tension to a tether of the prosthetic valve; a valve retention tube configured to be connected to a distal end of the loading handle assembly and configured to receive the prosthetic valve through a distal end of the valve retention tube; a valve assembly connected to the distal end of the valve retainer tube and including a funnel according to claim 1 and a centering cone receivable in the cone portion of the passage of the funnel; A valve loading assembly comprising:

11. 1. A method of compressing a prosthetic heart valve for delivery to a patient, comprising: placing the prosthetic heart valve in a loading funnel, the prosthetic heart valve including a frame defining a collar configured to contact an annulus of a native heart valve, the collar including an anterior portion configured to contact an anterior portion of the annulus and a posterior portion configured to contact a posterior portion of the annulus; translating the prosthetic heart valve through a loading funnel from a distal end of the loading funnel to a proximal end of the loading funnel to compress the prosthetic heart valve, the loading funnel including a passage extending between the distal and proximal ends of the loading funnel, the passage including a tapered portion that is wider at the distal end than at the proximal end, the passage further including at least two fins on an inner surface of the tapered portion of the passage, the at least two fins projecting away from the inner surface of the tapered portion of the passage toward a central longitudinal axis of the passage; Including, each portion of the collar advances along the at least two fins while translating the prosthetic heart valve through the loading funnel. method.

12. The method of claim 11 , wherein the front portion and the rear portion together provide a full perimeter of the collar.

13. 12. The method of claim 11, wherein during translation of the prosthetic heart valve through the loading funnel, the forward portion of the collar contacts only a forward section of the tapered portion, the forward section being devoid of internal fins.

14. 12. The method of claim 11, further comprising pulling the prosthetic heart valve proximally against the fins and into a retaining tube secured to the proximal end of the loading funnel, each of the fins extending from a respective relatively proximal position to a respective relatively distal position.

15. The artificial heart valve comprises: a generally tubular neck configured to extend through the native heart valve when the prosthetic heart valve is implanted; the frame defines the collar about an end of the neck, the collar including the forward portion and the rearward portion, the forward portion extending radially farther from the neck than the rearward portion, and two hips each located at a respective point where the forward portion meets the rearward portion, the positioning step comprising: symmetrically aligning said hips on either side of the plane in which said fins are symmetrically distributed; Including, The method of claim 11.

16. The method of claim 15 , wherein the positioning step includes angularly aligning two of the fins and the hip about the cone axis.

17. 17. The method of claim 16, wherein the placing step includes mounting the anterior portion of the prosthetic heart valve to contact the conical portion only within a anterior section of the conical portion and mounting the posterior portion of the prosthetic heart valve to contact the conical portion only within a posterior section of the conical portion, the anterior section and the posterior section being defined between the two fins, the section being devoid of fins.

18. 12. The method of claim 11, wherein the positioning step includes angularly aligning the prosthetic heart valve about the cone axis such that only the posterior portion contacts the fins.

19. 12. The method of claim 11, wherein the at least two fins are exactly two fins, each of the fins extending along a respective fin axis, and the cone axis and the fin axis are encompassed by a common plane.

20. The method of claim 11 , wherein the at least two fins is exactly three fins.

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